BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23649805 · Received November 25, 2025

    Report

    Report Number
    3015537318-2025-00112
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 25, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS NOT BELIEVED TO BE THE CAUSE OF THE ADVERSE EVENT. TREATING PHYSICIANS FELT IT WAS DUE TO PATIENT'S ANATOMY AND ADDITIONAL COMORBIDITIES LEADING UP TO THE EVENT INCLUDING A LARGE PULMONARY EMBOLISM AND SUBSEQUENT RIGHT HEART STRAIN. IN ADDITION, EXTRAVASATION AND PSEUDOANEURYSM ARE KNOWN ADVERSE EVENTS LISTED IN THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP IFU AND LABEL.

    Description of Event or Problem · 0

    ON OCTOBER 28, 2025, A PROVIDER REQUESTED IMMEDIATE GUIDANCE FOR A PATIENT PRESENTING WITH AN ACUTE INTRA-ABDOMINAL BLEED AND BEING TRANSPORTED TO THE INTERVENTIONAL RADIOLOGY (IR) SUITE. THE PATIENT PREVIOUSLY UNDERWENT HAI PUMP IMPLANTATION ON (B)(6) 2025. ON PRESENTATION, IMAGING (CTA) DEMONSTRATED ARTERIAL EXTRAVASATION, RAISING CONCERN FOR A SMALL PSEUDOANEURYSM NEAR THE CATHETER TIP AT THE GASTRODUODENAL ARTERY (GDA). THE PATIENT HAD ALSO UNDERGONE AN EXPLORATORY LAPAROTOMY WITHOUT IDENTIFICATION OF A DISCRETE BLEEDING SOURCE. THE PROVIDER INQUIRED ABOUT THE RISKS AND POTENTIAL CONTRAINDICATIONS OF PERFORMING A PUMP ANGIOGRAM CONCURRENTLY WITH A PLANNED CELIAC ANGIOGRAM. A DISCUSSION WAS HELD REGARDING THE RISK OF RUPTURE ASSOCIATED WITH INCREASED INJECTION PRESSURE THROUGH THE PUMP IN THE SETTING OF A SUSPECTED PSEUDOANEURYSM. THE PROVIDER REQUESTED CONFIRMATION OF WHETHER THIS APPROACH WAS CONTRAINDICATED. A SAME-DAY, URGENT PEER-TO-PEER CONSULTATION WAS FACILITATED TO SUPPORT IMMEDIATE CLINICAL DECISION-MAKING. THE CLINICAL TEAM PLANS TO PROCEED WITH A CELIAC ANGIOGRAM VIA STANDARD IR ACCESS TO EVALUATE AND MANAGE THE BLEEDING SOURCE. THEY WILL NOT PROCEED WITH ANGIOGRAPHY THROUGH THE PUMP DUE TO THE RISK OF ARTERIAL RUPTURE ASSOCIATED WITH INJECTION PRESSURE IN THE PRESENCE OF A SUSPECTED PSEUDOANEURYSM. PUMP SACRIFICE REMAINED A CONSIDERATION IF REQUIRED FOR HEMOSTASIS, WITH POSSIBLE MANAGEMENT OPTIONS INCLUDING COIL EMBOLIZATION OF HA OR STENT PLACEMENT TO PRESERVE HEPATIC INFLOW. THE SURGEON WHO PLACED THE PUMP, LATER UPDATED INTERA ONCOLOGY AND MENTIONED THAT THERE WAS A SUSPECTED BLEED AT THE HEPATIC ARTERY. THEY PLACE A STENT IN THE HEPATIC ARTERY, WHICH HAS OCCLUDED THE GDA ENTRY INTO THE HEPATIC ARTERY, SO THE PUMP IS NO LONGER VIABLE. THEY ARE REMOVING ALL RESIDUAL VOLUME FROM THE PUMP AND WILL REMOVE THE PUMP AFTER THE PATIENT HAS RECOVERED FROM THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537990 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30766679 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R| O